# K071079: Spectra Optia  Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Bct, Inc.
- Decided: Aug 2, 2007 after 107 days
- Product code: LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic)
- Device class: U
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K141938: Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set) (2015), 2 descendants of its own
- K151368: Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter (2015), 1 descendant of its own
- K153601: Spectra Optia Apheresis System (2016), 0 descendants of its own
- K131744: Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia System Software (2013), 0 descendants of its own

## Recalls of this device
- Oct 26, 2011 · Not classified · Z-1504-2012: Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed.
- Sep 21, 2011 · Not classified · Z-0191-2012: Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
- Dec 9, 2010 · Not classified · Z-2674-2011: An additional air detection system is being added to all existing systems to detect air in the system's return line.
- Sep 18, 2007 · Not classified · Z-0078-2008: Under specific conditions, apheresis machine could return up to 60mL of air to the patient.

## Indications for use
The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.

Source page: https://510kreport.com/device/K071079
Methodology: https://510kreport.com/methodology